identify the potential threat of biosimilars & examine their impact on
the prescription & development of new biologics now & in the future;

analyze the market trends & highlight future market opportunities.

KEY FINDINGS:

From the 1990s onwards, growing insight into the biological processes
responsible for disease led to a drive to develop treatments based on the
biological contributors to in disease processes. Thus, began the
biopharmaceutical era, and an accompanying shift of focus to large-molecule
compounds.

The biopharmaceutical market is now estimated to be worth over US$78 billion
in 2009 growing by 15% per annum, focusing on two key areas, monoclonal
antibodies and biological active proteins and driven by advances in
biotechnology, manufacturing and delivery.

TPs have been widely used to treat a wide range of diseases including:
diabetes, growth hormone deficiencies, blood disorders, immuno-inflammatory
related diseases. Numerous products are under development for these and other
conditions, such as cancer and gastrointestinal disorders.

The introduction of recombinant DNA technologies and genetic engineering has
revolutionized the production of mAb and TPs. The modification of antibody
mediated techniques (phage display) and the adoption of high throughput
screening technologies has improved productivity and the reproducibility of
complex proteins, which is central to discovery and characterisation of new TPs.

Regulatory agencies from the US, Europe, and Japan are making efforts to
collaborate and coordinate their requirements, in order to achieve global
regulatory compliance. However, differences in government structures, cultural
norms, and business environments still lead to differences in interpreting and
implementing international guidelines.

The launch of biosimilars provides new challenges and threats for the
biologics industry. Relatively few biosimilars have been launched to date due to
high financial technical and regulatory barriers to entry; however those that
have reached the marker are available at between 20%-30% discount to branded
products. Biologic manufacturers are already developing second generation
products with improved efficacy, safety and/or pharmacokinetic profiles to keep
one step ahead of the competition.

The next phase of pharmaceutical medicine will be driven by fundamental
scientific advances in the understanding of diseases and the development of
personalised medicines. However, significant challenges remain to improve the
cost-effective manufacture and production of biologics, and to enhance their
delivery, pharmacokenetics and reduce immunogenicity. Despite these issues
recent advances in mAbs and TPs technologies continue to drive innovation and
meet the markets need to treat the right patient at the right time.